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FDA 510(k)

LEECO T3-QUANT DIAG. KIT

K-Number: K834348 · 1984-02-21

ApplicantLeeco Diagnostics, Inc.
Decision Date1984-02-21
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO T3-QUANT DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834348. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO T3-QUANT DIAG. KIT?

LEECO T3-QUANT DIAG. KIT is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K834348.

When did LEECO T3-QUANT DIAG. KIT receive FDA 510(k) clearance?

LEECO T3-QUANT DIAG. KIT received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834348.

Who is the listed applicant for LEECO T3-QUANT DIAG. KIT?

The FDA 510(k) record lists Leeco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEECO T3-QUANT DIAG. KIT?

The FDA product code for LEECO T3-QUANT DIAG. KIT is CDP.

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Other records listing Leeco Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K895765LEECO PREVIEW(R) EBV (EIA)K894122LEECO VIS-DISK STREP-A (EIA)K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK891096VIS-DISK HCG (EIA) JPL-041MK883269PRL-QUANTK880577CONCEP-7-BHCG

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Related Devices (Code: CDP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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